Intocell Receives IND Approval from Korean Ministry of Food and Drug Safety for Solid Tumor Therapy Following U.S. FDA

On December 2, Intocell announced that it has received approval from the Ministry of Food and Drug Safety for its Phase 1 clinical trial plan (IND) for the investigational treatment 'ITC-6146RO' targeting advanced solid tumors.

ITC-6146RO is an antibody-drug conjugate (ADC) candidate that targets B7-H3, which is expressed in metastatic castration-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), and triple-negative breast cancer (TNBC).

The clinical trial will enroll up to 102 patients with advanced or metastatic cancers who have failed standard therapies. The study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of ITC-6146RO.

An Intocell representative stated, "With this approval from the Ministry of Food and Drug Safety following the U.S. Food and Drug Administration (FDA), our technological capabilities have been recognized both domestically and internationally. We will continue to pursue technology transfers of our pipeline and expand new partnerships to become a globally competitive company."